Periodontal Treatment and Psychology

Gum Disease Clinical Trial

Official title:

The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190512
• Other study ID #: 14-KAEK-218
• Status: Completed
• Phase: N/A
• First received: June 12, 2017
• Last updated: June 15, 2017
• Start date: May 4, 2015
• Est. completion date: September 1, 2016

Study information

• Verified date: June 2017
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.

Description:

Background: Depression is a multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.

Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: September 1, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• the presence of periodontal diseases,

• the presence of diagnosed minor depression

• being under maintenance therapy regarding the depression

Exclusion Criteria:

• any hormonal condition such as pregnancy or lactation

• received any periodontal treatment within six months

Related Conditions & MeSH terms

• Gum Disease

Intervention

Other:
• Psychological measurements
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Ozge Gokturk

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression level	The changes in depression level within 6 weeks. Depression level was determined using the Beck Depression Inventory.	Baseline and after 6 weeks
Secondary	Body image level	The changes in body image level within 6 weeks. Body image level was determined using the Body Cathexis Scale.	Baseline and after 6 weeks
Secondary	Anxiety level	The changes in anxiety level within 6 weeks. Anxiety level was determined using the Beck Anxiety Inventory.	Baseline and after 6 weeks
Secondary	Self-esteem level	The changes in self-esteem level within 6 weeks. Self-esteem level was determined using the Rosenberg Self-Esteem Scale.	Baseline and after 6 weeks
Secondary	Probing pocket depth	The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.	Baseline and after 6 weeks
Secondary	Clinical attachment level	The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.	Baseline and after 6 weeks
Secondary	Gingival index	The changes in gingival index level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome.	Baseline and after 6 weeks
Secondary	Plaque index	The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.	Baseline and after 6 weeks
Secondary	Bleeding on probing	The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.	Baseline and after 6 weeks